Full Press Release Details
Announces Development Plans for Voclosporin in Europe and Japan
Phase III trial (AURORA) to serve as basis for regulatory submissions in
major markets-US, Europe, and Japan
VICTORIA, British Columbia--(BUSINESS WIRE)--April 6, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company"), today announced the outcome of discussions with both the
European Medicines Agency (EMA) and the Pharmaceutical and Medical
Devices Agency (PMDA) in Japan regarding the development of voclosporin
for the treatment of active lupus nephritis (LN). Pursuant to these
discussions, the Company believes that the confirmatory data that can be
generated from the single Phase III clinical trial (AURORA) and the
recently completed AURA-LV (AURA) Phase IIb study should support
regulatory submissions in the US, Europe and Japan.
"Our interactions with regulators in all three jurisdictions have given
us a clear pathway for Phase III, and we are confident in our ability to
execute AURORA successfully based on their feedback and the information
gleaned from the AURA study," said Lawrence D. Mandt, Vice President of
Quality and Regulatory Affairs at Aurinia. "The productive conclusion of
these regulatory interactions marks a milestone in our development
program and brings this exciting new therapeutic option one step closer
to those patients suffering from LN."
The Phase III AURORA trial will be a global 52-week double-blind,
placebo controlled study of approximately 320 patients. Patients will be
randomized 1:1: to either of 23.7mg voclosporin BID and mycophenolate
mofetil (MMF) or MMF and placebo, with both arms receiving a stringent
oral corticosteroid taper. As in AURA, the study population will be
comprised of patients with biopsy-proven active LN who will be evaluated
on the primary efficacy endpoint of complete remission, or renal
response, at 52 weeks, a composite which includes:
Urinary/protein creatinine ratio (UPCR) of 0.5mg/mg
Normal, stable renal function ( 60 mL/min/1.73m2 or
no confirmed decrease from baseline in eGFR of >20%)
Presence of sustained, low dose steroids ( 10mg prednisone from week
No administration of rescue medications
"Based on the recent learnings from the positive AURA study at 48 weeks,
we intend to use a UPCR of 0.5mg/mg and evaluate the primary endpoint
at 52 weeks in AURORA," added Richard M. Glickman, Aurinia's Chief
Executive Officer. "We are on track to initiating the global AURORA
study this quarter and fulfilling our goal of improving the long-term
outcomes for patients with this disease."
The AURORA study is a 52-week global
double-blind placebo controlled phase III study that will compare the
efficacy of one dose of voclosporin (23.7mg BID) or placebo added to
current standard of care of mycophenolate mofetil (MMF, also known as
CellCept ) in achieving renal response (formerly referred to as complete
remission) in patients with active LN. Both arms will also receive low
doses of corticosteroids as part of background therapy after a stringent
The AURA-LV study (Aurinia Urinary
Protein Reduction in Active Lupus with Voclosporin) was a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF against standard of care with placebo in
achieving complete remission (CR) in patients with active LN. All arms
also received low doses of corticosteroids as background therapy. 265
patients were enrolled at centers in 20 countries worldwide. On entry to
the study, patients were required to have a diagnosis of LN according to
established diagnostic criteria (American College of Rheumatology) and
clinical and biopsy features indicative of highly active nephritis. The
24-week primary and secondary endpoints were released in Q3 2016 with
top-line 48-week results announced in Q1 2017. The 48-week data has been
accepted for a late-breaking presentation at National Kidney Foundation
(NKF) Spring Clinical Meeting taking place April 18-22 in Orlando, FL.
Voclosporin, an investigational drug,
is a novel and potentially best-in-class calcineurin inhibitor ("CNI")
with clinical data in over 2,200 patients across indications.
Voclosporin is an immunosuppressant, with a synergistic and dual
mechanism of action that has the potential to improve near- and
long-term outcomes in LN when added to standard of care (MMF). By
inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell
mediated immune responses. It is made by a modification of a single
amino acid of the cyclosporine molecule which has shown a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency, an altered metabolic profile, and potential for
flat dosing. The Company anticipates that upon regulatory approval,
patent protection for voclosporin will be extended in the United States
and certain other major markets, including Europe and Japan, until at
least October 2027 under the Hatch-Waxman Act and comparable laws in
About Lupus Nephritis (LN)
LN in an inflammation of the
kidney caused by Systemic Lupus Erythematosus ("SLE") and represents a
serious progression of SLE. SLE is a chronic, complex and often
disabling disorder and affects more than 500,000 people in the United
States (mostly women). The disease is highly heterogeneous, affecting a
wide range of organs & tissue systems. It is estimated that as many as
60% of all SLE patients have clinical LN requiring treatment. Unlike
SLE, LN has straightforward disease outcomes where an early response
correlates with long-term outcomes, measured by proteinuria. In patients
with LN, renal damage results in proteinuria and/or hematuria and a
decrease in renal function as evidenced by reduced estimated glomerular
filtration rate (eGFR), and increased serum creatinine levels. LN is
debilitating and costly and if poorly controlled, LN can lead to
permanent and irreversible tissue damage within the kidney, resulting in
end-stage renal disease (ESRD), thus making LN a serious and potentially
life-threatening condition.
Aurinia is a clinical stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are suffering from
serious diseases with a high unmet medical need. The company is
currently developing voclosporin, an investigational drug, for the
treatment of LN. The company is headquartered in Victoria, BC and
focuses its development efforts globally. www.auriniapharma.com.